FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
125497–125520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 1990
COBAS READY CALIBRATOR KIT
K897097 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 187d
Cleared Jun 26, 1990
NAMIC PTCA Y-ADAPTOR
K900652 · DTL
North American Instrument Corp.
Cardiovascular · 137d
Cleared Jun 26, 1990
PV-CERAMIC, CERAMINIQUE
K901261 · EIH
Ivoclar North America, Inc.
Dental · 103d
Cleared Jun 26, 1990
MODEL MC 2100 ND:YAG SURGICAL LASER SYSTEM
K901340 · GEX
Klinger Medical
General & Plastic Surgery · 96d
Cleared Jun 26, 1990
CENTREMARK(TM) CENTRAL VENOUS CATHETER TRAY
K901374
Menlo Care, Inc.
General Hospital · 96d
Cleared Jun 26, 1990
DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER
K901391 · DYB
Datascope Corp.
Cardiovascular · 92d
Cleared Jun 26, 1990
NUTRIMIX MACRO TPN COMPOUNDER
K901404 · LHI
Abbott Laboratories
General Hospital · 92d
Cleared Jun 26, 1990
WURTZ CHOLEY CLIP (TM)
K901520 · GBZ
Cd Medical, Inc.
General & Plastic Surgery · 85d
Cleared Jun 26, 1990
MODIFIED OPUS VALPROIC ACID TEST SYSTEM
K901538 · LEG
Pb Diagnostic Systems, Inc.
Toxicology · 85d
Cleared Jun 26, 1990
GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM
K901545 · JWM
Toshiba America Medical Systems, In.C
Radiology · 84d
Cleared Jun 26, 1990
OPUS(TM) DIGOXIN TEST SYSTEM
K901547 · KXT
Pb Diagnostic Systems, Inc.
Toxicology · 84d
Cleared Jun 26, 1990
NEW PER-FIT(R) IMPROVED
K901621 · EBI
Dental Product Co.
Dental · 82d
Cleared Jun 26, 1990
RICH-MAR BP-2000 ELECTRICAL MUSCLE STIMULA. UNIT
K901779 · IPF
Rich-Mar Corp.
Physical Medicine · 70d
Cleared Jun 26, 1990
HELIO LINK (RESIN CEMENT)
K901910 · EBF
Ivoclar North America, Inc.
Dental · 61d
Cleared Jun 26, 1990
SYNTAC (DENTIN BONDING AGENT)
K901913 · KLE
Ivoclar North America, Inc.
Dental · 61d
Cleared Jun 26, 1990
HELIOTINT
K901918 · EBF
Ivoclar North America, Inc.
Dental · 61d
Cleared Jun 26, 1990
OPUS (TM) HCG
K901935 · JHI
Pb Diagnostic Systems, Inc.
Toxicology · 57d
Cleared Jun 26, 1990
OMRON TRAVEL TOOTHBRUSH, MODEL HT-B02
K901963 · JEQ
Omron Marshall Products, Inc.
Dental · 56d
Cleared Jun 26, 1990
WHITESIDE ORTHOLOC MODULAR POST. STAB. KNEE SYSTEM
K901992 · JWH
Dow Corning Wright
Orthopedic · 55d
Cleared Jun 26, 1990
P.F.C. HIP SYSTEM NON-POROUS ACETABULAR COMPONENT
K902137 · JDI
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 46d
Cleared Jun 26, 1990
MODIFIED STICK-GARD SAFETY NEEDLE
K902196 · FPA
Ziehm International, Inc.
General Hospital · 41d
Cleared Jun 26, 1990
MONITOR, MODEL 2817
K902334 · DXJ
Esaote Biomedica Spa
Cardiovascular · 33d
Cleared Jun 26, 1990
DISPOSABLE CORONARY CONTROL SYRINGE
K902346 · FMF
Advance Medical Designs, Inc.
General Hospital · 32d
Cleared Jun 26, 1990
RUBIN PATIENT EXAMINATION GLOVES
K902463 · LYY
P.T. Perkebunan
General Hospital · 22d